The present invention relates generally to breast fluid aspirators, and more specifically to an apparatus, a system, and a method for determining the risk of breast disease in a biological sample obtained from the breast by means of a breast fluid aspirator.
Breast cancer is one of the leading causes of disease and death in women, with greater than 90% of breast cancer originating in the epithelial cells of the ducts of the breast. Early detection and treatment of breast cancer has focused on improving prognosis and increasing the survival rates. Renewed focus on prevention and detection of breast cancer has lead to the use of numerous biological indicators and methods of early detection of breast cancer risk. Such indicators include numerous oncogenic determinants, cytokines, angiogenic factors, proteins and nucleic acids, as well as biochemical products and lipids.
Carotenoids and retinoids are naturally occurring substances which contain extensively conjugated polyene chains. Carotenoids have extensively conjugated systems of carbon-carbon double bonds which give rise to their many varied and brilliant colors. Many carotenoids and retinoids, are biologically active. For example, certain hydrocarbon members of the carotenoid family (most notably, xcex2-carotene, or pro-vitamin A, one of the most abundant carotenoids in food) are sources of retinol (one form of vitamin A). Carotenoids protect plants from photosensitized oxidative damage, probably by deactivating singlet oxygen. Epidemiological evidence indicates that carotenoid intake correlates inversely with the incidence of some types of cancer (Peto et al, Nature, 1981, 290, 201-208). Carotenoids and retinoids have been shown to retard the development of some experimentally induced animal tumors (N. I. Krinsky, Actions of Carotenoids in Biological Systems, Annu. Rev. Nutr, 13, 561-587 (1993); Matthews-Roth, Curr. Top. Nutr. Dis. (New Prot. Roles Select. Nutr.), 1989, 22, 17-38; Pure Appl. Chem., 1985, 57, 717-722). A number of dietary intervention studies are being carried out to try to determine the efficacy of supplemental xcex2-carotene as a non-toxic, dietary anticarcinogen that can effectively decrease cancer mortality. Recently, the possibility has begun to be examined that xcex2-carotene may be associated with decreased incidence of coronary heart disease. Recent clinical data using related compounds (retinoidsxe2x80x94retinoic acid, retinol, and retinamides) have demonstrated a role in anti-cancer therapy, both as a therapeutic and a preventive agent (cancers of the skin, head and neck, lung and bladder, acute promyelocytic leukemia, leukoplakia and myelodysplastic syndromes; D. L. Hill and C. J. Grubs, Retinoids and Cancer Prevention, Annu. Rev. Nutr. 1992, 12, 161-181). Furthermore, xcex2-carotene has antioxidant properties at the low oxygen pressures found in tissues (Burton and Ingold, xcex2-Carotene: an unusual type of lipid antioxidant, Science, 1984, 224, 569-573).
The protective effect of lactation and dietary carotenoids in breast cancer development has been reported (American Cancer Society, 1996; Holmes, Hunter, and Willett, 1995, Stoll, 1996; and Weisburger, 1991). However, little is known about the role of lactation in influencing transport of carotenoids into the micro environment of the breast.
In one embodiment, the invention provides a method for detecting a biological factor in a fluid sample obtained from a mammary gland, comprising non-invasively obtaining a mammary gland fluid from a subject by warming the mammary gland; massaging the mammary gland from the chest wall towards the nipple; extracting the mammary fluid from the nipple by expression and/or aspiration and detecting the biological factor in the mammary gland fluid.
In another embodiment, the invention provides a method of determining a risk of a mammary gland disease in a subject comprising non-invasively obtaining a mammary gland fluid from the subject, comprising warming the mammary gland; massaging the mammary gland from the chest wall towards the areola or nipple; and aspirating the mammary fluid; quantifying the amount of a biological factor in the mammary fluid; comparing an amount of the biological factor to the amount of the biological factor in a control sample, wherein the ratio of the biological factor in the fluid to the control sample is indicative of the risk of mammary gland disease.
In yet another embodiment, the invention provides a method of determining the risk of breast cancer in a subject comprising quantifying the amount of a carotenoid in a biological sample obtained from a mammary gland compared to an amount of a carotenoid in a control sample, wherein if a ratio of carotenoids in the biological sample to the carotenoids in the control sample is less than one the ratio is indicative of a risk of breast cancer.
In another embodiment, the present invention provides a method for increasing the amount of carotenoids in a mammary gland, comprising warming the mammary gland; massaging the mammary gland from the chest wall towards the areola or nipple; and aspirating a mammary fluid from the mammary gland.
In another embodiment, the invention provides a non-invasive method for obtaining a biological sample from a mammary organ of a subject, comprising massaging the mammary gland tissue from the chest wall towards the nipple; placing the thumb and first fingers behind the nipple forming a C-hold; pushing the nipple into the chest wall; and rolling thumb and fingers forward toward the nipple.
In yet another embodiment, the invention provides an apparatus for collection of a biological sample from the mammary gland of a subject, comprising a nipple receiving unit having a tubular shape with a nipple receiving end designed to receive a nipple and a second vacuum attachment end for attachment to a vacuum line; a vacuum line having a first and a second end, wherein the second end is attached to the vacuum source and the first end is attached to the nipple receiving unit; and a vacuum source wherein the vacuum source is in vacuum communication with the nipple receiving end of the nipple receiving unit.
In another embodiment, the invention provides an apparatus for collection of a biological sample from a mammary gland of a subject, comprising a pliable mammary gland shield configured to fit snugly over the mammary gland of the subject, the shield having a massaging element configured to provide physical stimuli to the mammary gland; a nipple receiving unit centered radially in the mammary gland shield, wherein the nipple receiving unit comprises a tubular shape with a nipple receiving end designed to receive a nipple and a second vacuum attachment end for attachment to a vacuum line; a vacuum line, the vacuum line having a first end and a second end, the first end being connected to the nipple receiving unit; a vacuum source for creating a vacuum connected to the second end of the vacuum line, wherein the vacuum source is in vacuum communication with the nipple receiving end of the nipple receiving unit.